特罗凯说明书
特罗凯说明书
本品用于 EGFR 突变人群一线治疗的临床研究正在进行中。建议经治医生根据本品和同 类药物研究进展以及患者自身状况综合考虑适宜的治疗选择。
【规格】 （1）100 毫克 （2）150 毫克
【用法用量】 本品必须在有此类药物使用经验的医生指导下使用。 厄洛替尼单药用于非小细胞肺癌的推荐剂量为 150mg/日，至少在饭前 1 小时或饭后 2
厄洛替尼的安全性评估是基于 1200 多例至少接受过一次 150mg 厄洛替尼单药治疗患者
的数据和 300 多例接受过厄洛替尼 100mg 或 150mg 联合吉西他滨治疗患者的数据，以及 1228
例接受厄洛替尼联合化疗患者的数据。
来自于临床试验中厄洛替尼单药或联合化疗报告的不良反应 （ADR） 总结如下。下
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优先术语 皮疹 腹泻 疲劳 厌食 瘙痒 痤疮 痤疮样皮炎 皮肤干燥 体重下降 甲沟炎
所有分级% 49.2 20.3 9.0 9.2 7.4 6.2 4.6 4.4 3.9 3.9
III 级% IV 级%
6.0
0
1.8
0
TORK-LOK 拧紧锁筒和椅子系列说明书
Precision Mated Flats on Both Expander and Arbor BodyPrecision Mated Flats on ColletSafety Stops Contraction ExpansionTork-Lok Arbors and ColletsTORK-LOK ARBORS AND COLLETSThe Tork-Lok arbor design answers the need for a completely versatile workholding device. Precision ground flats on collets and arbors improve long-term accuracy and torque transmission. Standardization of components permits interchangeability and combination possibilities. Locates straight or tapered holes on true center.INSTALLATION AND OPERATING INSTRUCTIONSSafety StopsThe expansion safety stop is fixed in all styles and requires no adjustment. The contraction or loading position safety stop is adjusted to suit the part being chucked.PreloadAll collets are manufactured to include a preload. Collets should not be adjusted below the range minimum for that collet. Preloads are .008 average on sizes from .500-.874 and .015 from .875-4.467.Special Work Stop ConsiderationCombination Work Stop and Retaining Sleeve: Restrictor Type Work Stops are necessary for parts whose gripping length is shorter than the collet. Since the Tork-Lok collet expands at both ends, a retaining sleeve is needed to prevent the free end of the collet from over expanding; a Restrictor Expander is used to reduce the expansion safety stop, preventing collet breakage (in case arbor is operated without a part in position).NOTES:• All Tork-Lok arbor applications require a part stop• If Restrictor Type Stop is used, a special Restrictor Expander is required • Contact us at 1-800-228-BUCK for more informationDRAWBAR MODELDrawbar should be in forward or push position. Adjust forwardexpander with Allen wrench until part is a slip fit on the collet. Collet flats both ends must mate.Collet ChangingDrawbar should be in forward positions. Using Allen wrench, remove forward expander. Collet and rubber sleeve can then be removed. Wash parts in clean solvent. Lightly grease expander flats in contact. Install forward expander. Adjust according to instructions outlined above.AIR-OPERATED MODELAir pressure on the cylinder should be at 70 psi. Adjust forward expander with Allen wrench until part is slip fit on the collet. Collet flats on both ends must mate.Collet ChangingWith air pressure at 70 psi, follow instructions listed in Drawbar Model.To Interchange AssembliesApply 70 psi, remove mounting screws, turn arbor assembly counterclockwise until drawbar disengages from piston assembly.To mount assembly, apply 70 psi. Be sure threads on drawbar are clean and oiled. Turn arbor assembly clockwise until face contacts cylinder. Back off to align tapped holes in cylinder. Insert screws and adjust according to instructions outlined above.Expansion StopForward ExpanderDirt Seal Contraction StopDrawbar ConnectorForward ExpanderExpansion StopContraction StopNote: Max. Drawbar pullstamped hereDirt SealChip ClearanceMachine ID of sleeve to high limit of part +.02 - +.004AIR-OPERATED MODELDRAWBAR MODELTYPICAL APPLICATIONS FOR ARBORSPISTON DIFF. CARRIER TRACK ROTOR BALL JOINT GEAR BLANK PUMP HOUSINGCOMPRESSION PLATEFRONT BRAKE DRUMSpecial arbor combinations are available upon request. Please contact us at 1-800-228-BUCK for more information.Arbor Applications36Tork-Lok Drawbar ModelsLong Series ArborsFEATURES AND BENEFITS:• Answers your need for versatility• Precision-ground flats improve accuracy• Standardization permits interchangeability• Locates straight or tapered holes on true center• Requires a part stopSHIPS COMPLETE WITH:• Flange body• Connector• Expander•Collet sold separately; see pages 40 & 41FEATURES AND BENEFITS:• Bolt circle has versatile three-bolt pattern • Tighter tolerance on size and parallelism for locator mounting• Provisions for air sensing• Precision-ground flats improve accuracy • Standardization permits interchangeability• Locates straight or tapered holes on true center • Requires a part stopTork-Lok Metric Drawbar ModelsLong Series ArborsDimensions denoted in millimeters unless otherwise specified.SHIPS COMPLETE WITH:• Flange body • Connector • Expander• Collet sold separately; see pages 40 & 41- Optional assembly method with male thread38SHIPS COMPLETE WITH:• Flange body • Connector • Expander• Collet sold separately; see pages 40 & 41FEATURES AND BENEFITS:• Answers your need for versatility• Precision-ground flats improve accuracy • Standardization permits interchangeability• Locates straight or tapered holes on true center • Requires a part stopTork-Lok Drawbar ModelsShort Series Arbors1-800-228-BUCK 39Tork-Lok Metric Drawbar ModelsShort Series ArborsFEATURES AND BENEFITS:• Bolt circle has versatile three-bolt pattern • Tighter tolerance on size and parallelism for locator mounting• Provisions for air sensing• Precision-ground flats improve accuracy • Standardization permits interchangeability• Locates straight or tapered holes on true center • Requires a part stopSHIPS COMPLETE WITH:• Flange body • Connector • Expander• Collet sold separately; see pages 40 & 41- Optional assembly method with male threadT o r k -L o k L o n g S e r i e s C o l l e tsF E A T U R E S A N D B E N E F I T S :• P r e c i s i o n g r o u n d fla t s • C o l l e t s i n t e r c h a n g e a b l e o n a l l a r b o r s w i t h i n s p e c i fie d r a n g e • A c c u r a c y o f a r b o r n o t a f f e c t e d b y i n d e x i n g o f c o l l e t s h a f t • H i g h -g r a d e s t e e l s , p r e c i s e l y h e a t t r e a t e d • S i l i c o n e s e a l i n g o f c o l l e t s l o t s f o r s p e c i a l j o b s i s a v a i l a b l e o n r e q u e s t f o r a d d i t i o n a l c h a r g e • C o l l e t s i n o v e r s i z e (o v e r l a p ) r a n g e s a r e a v a i l a b l e – s e e b o l d r a n g esO v e r s i z e c o l l e t s A C 107-110;209-212 a n d 311-318 s h o u l d b e u s e d o n l y i n l i g h t t u r n i n g o r g r i n d i n g o p e r a t i o n s .T o r k -L o k S h o r t S e r i e s C o l l e tsF E A T U R E S A N D B E N E F I T S :• P r e c i s i o n g r o u n d fla t s • C o l l e t s i n t e r c h a n g e a b l e o n a l l a r b o r s w i t h i n s p e c i fie d r a n g e • A c c u r a c y o f a r b o r n o t a f f e c t e d b y i n d e x i n g o f c o l l e t s h a f t • H i g h -g r a d e s t e e l s , p r e c i s e l y h e a t t r e a t e d • S i l i c o n e s e a l i n g o f c o l l e t s l o t s f o r s p e c i a l j o b s i s a v a i l a b l e o n r e q u e s t f o r a d d i t i o n a l c h a r g e • C o l l e t s i n o v e r s i z e (o v e r l a p ) r a n g e s a r e a v a i l a b l e – s e e b o l d r a n g esO v e r s i z e c o l l e t s A C 7110-7115; 7213-7220 a n d 7317-7328 s h o u l d b e u s e d o n l y i n l i g h t t u r n i n g o r g r i n d i n g o p e r a t i o n s .4142Tork-Lok Replacement ComponentsSold in KitsAir-Operated ModelsMeasurements in inches.1-800-228-BUCK 43Manual Tork-Lok FixturesOPERATING INSTRUCTIONS1. Mount fixture on machine.2. Adjust expander with Allen wrench so that part is a slip fit on collet. Be sure collet and arbor flats mate on both ends.3. To clamp part, move handle clockwise.4. To release part, move handle counterclockwise.ORDERING INSTRUCTIONSA complete fixture is ready to mount on your machine. When ordering additional arbor assemblies for fixture use, indicate connector also. When ordering base assemblies, indicate connector(s) desired.TO CHANGE ARBOR ASSEMBLIESFrom one size range to another (see chart above for arbor assembly and connector):1. Remove cap screws and turn arbor assembly off the base clockwise.2. CAUTION Handle must be in unlocked position.3. Turn replacement arbor assembly counterclockwise into base until snug. Continue movement until holes line up. Replace cap screws.ADAPTATION OF DRAWBAR MODELS1. Procure proper fixture base and connectors to accommodate drawbar model you have (see chart above).2. Remove drawbar connector (A) by backing out expander (B) with Allen wrench until connector is free. Remove retaining ring.3. Insert fixture connector (C or D) by turning in expander (B) until flats mate and are firm on both ends. No retainer ring is necessary.4. CAUTION Handle must be in unlocked position.5. Turn assembly counterclockwise into base assembly until snug. Continue movement until holes line up. Replace cap screws.Installation and Operating InstructionsTORK-LOK FIXTUREThe Tork-Lok Fixture is a powerful locking mechanism for use with Tork-Lok Arbors. It features low initial cost and little maintenance for milling and drilling operations.onArbor AssemblyBase Assembly Locked PositionUnlocked PositionOUR BRANDSFORKARDT MAIN OFFICE 2155 Traversefi eld Dr Traverse City, MI 49686Tel: (+1) 800-544-3823Fax: (+1) 231-995-8361E-Mail:*****************FORKARDT CHINABuilding, No.209, Taigu Road Shanghai Waigaoqiao F .T.Z.200131 P .R.CTel: 86-021-********E-mail:****************.comFORKARDT DEUTSCHLAND GMBH Heinrich-Hertz-Str. 7D-40699 ErkrathTel: (+49) 211-25 06-0Fax: (+49) 211-25 06-221E-Mail:*****************FORKARDT FRANCE S.A.R.L.28 Avenue de BobignyF-93135 Noisy le Sec Cédex Tel: (+33) 1-4183 1240Fax: (+33) 1-4840 4759E-Mail:****************************FORKARDT INDIA L.L.P .P No. 39, No. 5-5-35/187Ayyanna Ind Park IE Prashant Nagar Kukatpally, Hyderabad, AP . 500072Tel: 040-40020571Fax: 040-40020576E-mail:**********************。
专家称特罗凯疗效显著.docx
认识认识丙卡巴肼药物名称：丙卡巴肼药物别名：Procarbazine甲苄肼、甲基苄肼，Methylhydrazine，NATULAN，MATULAN，PCB，PCZ，MZH英文名称：Procarbazine说明：片剂：每片50mg。
功用作用：主要用于霍奇金病，有1/3～1/2的病人能获得完全缓解，缓解期为3周～6个月或更长。
对其他恶性淋巴瘤、多发性骨髓瘤和肺癌亦有一定疗效。
用法用量：一般每日150～200mg，分3～4次服用。
一疗程总量可根据血象而定。
注意事项：常见的不良反应有：①胃肠道反应，主要为恶心、呕吐，多数能耐受。
②骨髓抑制，一般出现较晚，多在服药后4～6周出现，主要表现为白细胞和血小板下降，其程度与剂量有关。
停药后2～3周可恢复到正常水平。
③神经系统，部分病人可出现中枢神经系统毒性如眩晕、嗜睡、精神错乱、脑电图不正常等。
亦可出现下肢感觉异常、深反射消失、麻痹等周围神经炎的表现。
④其他，皮炎、脱发。
本品为弱的单胺氧化酶抑制剂，服药期间凡含有高酪胺成分的食物如乳酪和香蕉等均不宜食用。
若同时用拟交感神经药和抗抑郁剂丙咪嗪则应小心。
酒类宜少用。
与苯噻嗪类药物有协同的镇静作用，与巴比妥类、麻醉药、抗组织胺类和利血平等合用亦应谨慎。
本品可引起溶血性贫血，对肝、肾功能或骨髓机能不全的病人应减少剂量。
少数年轻妇女服药后可引起闭经。
：想知道还有哪些抗肿瘤药吗？[详情请看>>>>抗肿瘤药点滴]想了解更多肿瘤的相关知识，请点击>>>>癌症频道网址： 第 1 页，共 1 页。
特洛哥氯液141说明书
Product Data SheetTrigonox 1412,5-Dimethyl-2,5-di(2-ethylhexanoylperoxy) hexaneTrigonox® 141, 2,5-Dimethyl-2,5-di(2-ethylhexanoylperoxy)hexane, is a di-functional perester which is used for the curing of unsaturated polyester resins at high temperatures. Trigonox® 141 is preferred for the curing of UP resin based Hot Press Molding formulations (such as DMC and BMC) in the temperature range of 120 - 160°C. Trigonox® 141 is preferably used in combination with a low reactive peroxide like Trigonox® C or Trigonox® BPIC-C75 and an optimal low Profile SMC formulation for the production of HPM parts with a Class A surface at short molding times.CAS number13052-09-0EINECS/ELINCS No.235-935-5TSCA statuslisted on inventorySpecifications2,5-dihydroperoxy-2,5-dimethylhexane≤ 2.2 %Appearance Clear liquidAssay≥ 92.0 %Color≤ 20 Pt-CoInorganic + organic hydrolysable chloride≤ 100 mg/kgCharacteristicsDensity, 20 °C0.956 g/cm³Viscosity, 20 °C80 mPa.sApplicationsTrigonox® 141 can be used for the market segments: polymer production and thermoset composites with their different applications/functions. For more information please check our website and/or contact us.Thermal stabilityOrganic peroxides are thermally unstable substances, which may undergo self-accelerating decomposition. The lowest temperature at which self-accelerating decomposition of a substance in the original packaging may occur is the Self-Accelerating Decomposition Temperature (SADT). The SADT is determined on the basis of the Heat Accumulation Storage Test.SADT35°C (95°F)Emergency temperature (Tₑ)25°C (77°F)Control temperature (Tc)20°C (68°F)Method The Heat Accumulation Storage Test is a recognized test method for thedetermination of the SADT of organic peroxides (see Recommendations on theTransport of Dangerous Goods, Manual of Tests and Criteria - United Nations, NewYork and Geneva).StorageDue to the relatively unstable nature of organic peroxides a loss of quality can be detected over a period of time. To minimize the loss of quality, Nouryon recommends a maximum storage temperature (Ts max. ) for each organic peroxide product.Ts max.15°CNote When stored according to these recommended storage conditions, Trigonox®141 will remain within the Nouryon specifications for a period of at least 3 monthsafter delivery.Packaging and transportThe standard packaging is a 30-liter HDPE can (Nourytainer®) for 25 kg peroxide. Both packaging and transport meet the international regulations. For the availability of other packed quantities consult your Nouryon representative. Trigonox®141 is classified as Organic peroxide type C; liquid, temperature controlled, Division 5. 2; UN 3113.Safety and handlingKeep containers tightly closed. Store and handle Trigonox® 141 in a dry well-ventilated place away from sources of heat or ignition and direct sunlight. Never weigh out in the storage room. Avoid contact with reducing agents (e. g. amines), acids, alkalis and heavy metal compounds (e. g. accelerators, driers and metal soaps). Please refer to the Safety Data Sheet (SDS) for further information on the safe storage, use and handling of Trigonox® 141. This information should be thoroughly reviewed prior to acceptance of this product. The SDS is available at /sds-search.Major decomposition productsCarbon dioxide, Acetone, 2-Pentanone, Heptane, Heptenes, tert-Amyl alcohol, 2,5-Bis(1-ethylpentoxy)-2,5-dimethylhexane, 2,5-Dimethyl-2,5-hexanediolAll information concerning this product and/or suggestions for handling and use contained herein are offered in good faith and are believed to be reliable.Nouryon, however, makes no warranty as to accuracy and/or sufficiency of such information and/or suggestions, as to the product's merchantability or fitness for any particular purpose, or that any suggested use will not infringe any patent. Nouryon does not accept any liability whatsoever arising out of the use of or reliance on this information, or out of the use or the performance of the product. Nothing contained herein shall be construed as granting or extending any license under any patent. Customer must determine for himself, by preliminary tests or otherwise, the suitability of this product for his purposes.The information contained herein supersedes all previously issued information on the subject matter covered. The customer may forward, distribute, and/or photocopy this document only if unaltered and complete, including all of its headers and footers, and should refrain from any unauthorized use. Don’t copythis document to a website.Trigonox®, Nourytainer and Perkadox are registered trademarks of Nouryon Functional Chemicals B.V. or affiliates.Contact UsPolymer Specialties Americas************************Polymer Specialties Europe, Middle East, India and Africa*************************Polymer Specialties Asia Pacific************************2023-1-11© 2023Thermoset composites Trigonox 141。
印度特罗凯中文说明书
印度特罗凯中文说明书【药品名称】商品名：特罗凯[1]通用名：盐酸厄洛替尼片英文商品名：Tavceva英文通用名：Erlotinib HCL Tablets份子结构名：盐酸厄洛替尼片化学名称：N-(3-乙炔苯基)-6,7-双(2-甲氧乙氧基)-4-喹啉胺盐酸盐化学结构式：分子式：C22H23N3O4·HCl分子量：429.90【成份】每片内含150mg厄洛替尼（以盐酸厄洛替尼形式存在）【性状】圆形、双凸、白色包衣片。
【作用机制】Tarceva的抗肿瘤作用机制主要为抑制表皮生长因子（EGFR）酪氨酸激酶胞内磷酸化。
【药代动力学】Tarceva口服后60%吸收，半衰期约36小时，主要由CYP3A4代谢清除。
口服Tarceva150mg的生物利用度约60%，4小时后达血浆峰浓度。
对591例接受单药Tarceva治疗的药代动力学分析显示，达到稳定血药浓度需7-8 天，患者的年龄、体重、性别与药物的清除速率无显著关系，吸烟可使药物清除率增加24%。
【适应症】Tarceva用于两个或两个以上化疗方案失败的局部晚期或转移的非小细胞肺癌的三线治疗。
【禁忌症】对本品及成份过敏者禁用。
【不良反应】最常见的不良反应是皮疹和腹泻，3/4度皮疹和腹泻的发生率分别为9%和6%，皮疹的中位出现时间是8天，腹泻中位出现时间为12天。
发生率大于10%的不良反应有：皮疹、腹泻、食欲减低、疲劳、呼吸困难、咳嗽、恶心、感染、呕吐、口腔炎、瘙痒、皮肤干燥、结膜炎、角膜结膜炎、腹痛。
肺毒性：有较少的报道提示在接受Tarceva治疗的NSCLC患者或其他实体瘤患者中可出现严重的间质性肺病（ILD），甚至导致死亡。
在随机对照研究中，ILD的发生率是0.8%，并且这一发生率在Tarceva治疗组和安慰剂组是相同的。
报道的ILD包括：肺炎、间质性肺炎、间质性肺病、闭塞性细支气管炎、肺纤维化、急性呼吸应激综合征和肺渗出。
症状发生于治疗后5天~超过9个月，中位发生时间为47天。
药物肝损伤
药物性肝损伤风险的新视点肝脏是药物代谢的主要脏器，同时，也是药物损伤的主要靶器官。
药物性肝损伤( drug-induced liver injury，DILI) 是指药物在治疗过程中，由于药物本身或其代谢产物引起的肝细胞毒性损害或肝脏对药物及其代谢产物的过敏反应所致的疾病。
DILI 发病机制的复杂性和疾病的隐匿性，往往导致其在药品在上市前的临床试验中不能完全被发现，而是在药品大量用于临床后才逐渐显现出来。
有统计结果显示，引起DILI 的药物有600 余种。
随着医药的研发，新药不断问世、用于临床，新药上市后的安全性问题越来越引起关注。
笔者查阅了近几年美国食品药品监督管理局( FDA) 、国家食品药品监督管理总局( CFDA) 、欧洲及加拿大等发布的DILI 相关报道，加以归纳、分析，以提示临床医务工作者关注和重视DILI 的风险，全面了解和掌握最新药品不良反应监测信息，降低或避免DILI 对患者带来更多、更严重的危害，保障公众用药安全。
1 修订说明书，警示肝损伤风险1. 1 丙硫氧嘧啶的肝损伤风险2010 年4 月，FDA 在甲状腺功能亢进症治疗药物丙硫氧嘧啶的药品说明书中添加黑框警告，提示其致严重肝损伤和急性肝衰竭的信息，其中包括成人和儿童患者使用该药品导致死亡的病例。
FDA 已发现34 例与丙硫氧嘧啶相关的严重肝损伤报告，23 例成年患者报告中，有13 例死亡和5 例肝移植病例; 11例儿科患者报告中，有2 例患者死亡，7例患者需要接受肝脏移植，1例患者在被列入移植名单时死亡。
另外，结合医学文献的回顾，FDA 得出结论，对于成年患者和儿科患者来说，丙硫氧嘧啶引起临床严重肝损伤甚至致命的风险比甲巯咪唑更高。
1. 2 加拿大修订说明书，警示莫西沙星的严重肝损伤风险2010 年3 月，加拿大卫生部发布修改处方类抗菌药物莫西沙星( moxifloxacin，商品名: Avelox) 药品说明书的通知，包括口服片剂和注射液。
Odor Hunter TM 商品说明书
MATERIAL SAFETY DATA SHEETSostram Corporation In Case of Emergency, Call300 Colonial Center Parkway, Suite 230 Sostram Corporation: 770-587-9807Roswell, GA 30076 CHEMTREC: 800-424-9300I.GENERAL INFORMATION1-Slight Health Hazard 0-Slight Flammability 1-Slight ReactivityAbove: Ratings based on NIOSH “Identification System for Occupationally Hazardous Materials” (1974).II.TRANSPORTATION INFORMATIONThis product is not regulated for transportation purposesThis product is below the maximum VOC limits established by the California Environmental Protection Agency Air Resource Board for this type of product as of last update 2005.III.PRODUCT IDENTIFICATIONProduct Name: Odor Hunter TMIV.HAZARDOUS INGREDIENTSThe substances listed below are those identified as hazardous chemicals under the criteria of the OSHA Hazard Communication Standard (29 CFR 1910.1200).Component CAS No. % AgencyTert-butanol 76-65-0 0.2 N/AV.PHYSICAL DATABoiling Point: 212 °F (100 °C)Freezing Point: Not determinedDensity Approximately 1 (8.34 lbs/gallon)Vapor Pressure at 20 °C: Not determinedWater Solubility: Completely MisciblepH: 8-10Viscosity: Not determined% Volatiles by Weight With the exception of water, none presentAppearance and Odor: Clear colorless liquid; fresh odorVI.FIRE AND EXPLOSION DATAFlash Point: >230 °F, >110 °CFlammability Limits in Air: Not established, this product is completely non-flammableExtinguishing Media: CO2, foam, dry chemical, water spraySpecial Fire Fighting Procedures: Move containers from fire area if you can do it without risk. Do not scatterspilled material with high-pressure water streams. Avoid breathing vapors,keep upwind. Positive pressure self-contained breathing apparatus with fullfacepiece and structural firefighters’ protective clothing will provide limitedprotection (1996 North American Emergency Guidebook- Guide 129).VII.HEALTH HAZARD INFORMATIONOral LD50 (rat): >5,000 mg/kgPrimary Dermal Irritation (rabbit): None irritatingDermal Sensitization – Buehler method: Non-contact sensitizerEmergency and First Aid ProceduresEyes: Flush eyes with plenty of water for at least 15 minutes holding eyelids apart to ensure flushing of the entire eye surface. Get medical attention immediately.Skin: Remove contaminated clothing promptly. Wash affected skin areas with soap and large amounts of water until no evidence of chemical remains (approximately 15 minutes). If irritation or rednessdevelops, get medical attention. Wash clothing before reuseInhalation: Remove subject to fresh air. If breathing is difficult, oxygen should be administered by qualified personnel. If breathing has stopped, perform artificial respiration. Keep person warm and at rest.Treat symptomatically and supportively. Get medical attention.Ingestion: Immediately drink two glasses of milk or gelatin mixture, or if these are not available, a large quantity of water. Avoid alcohol. DO NOT give anything by mouth if the person is unconscious or havingconvulsions. Get medical attention immediately.Possible routes of entry : Inhalation, ingestion, dermalAcute Health Effects:Eyes/Skin: Mild irritation is possibleIngestion: Mild gastrointestinal irritation with nausea, vomiting and/or diarrhea is possible Inhalation: None knownVIII.REACTIVITY DATAStability: Store at ambient temperatures.Incompatibility: Avoid contact with strong bases and ammonia. Stability in orwith other products must be tested on an individual basisHazardous Decomposition Products: None known.Hazardous Polymerization: Cannot occur.IX.SPILL, LEAK AND DISPOSAL PROCEDURESSpill or Leak:Dilute wash away spill by spraying area with plenty of water. When spraying area with water, avoid spraying in direction of any person(s). Avoid getting on clothing. Keep unnecessary people away. Avoid getting spilled material on clothing.Disposal:Disposal is to be performed in compliance with all federal, state and local regulations. Small quantities may be carefully disposed of down sewer drain using plenty of water.X.INDUSTRIAL HYGIENE CONTROL MEASURESSPECIFIC PERSONAL PROTECTIVE EQUIPMENTEYE: No requirement with casual use. Use goggles in an industrial setting.SKIN: No requirement with casual use. Use impervious gloves and impervious clothing to prevent repeated or prolonged skin contact.RESPIRATORY/VENTILATION: No respiratory protection is required for casual use. Local ventilation is notnecessary unless this material is used in an industrial setting. In this situationthe use of a mechanical fume hood or exhaust system will minimize exposureto vapor or mist. Alternatively use respiratory protection. The specificrespirator selected must be based on contamination levels found in the workplace and must be NIOSH/MSHA approved. A respiratory protectionprogram that meets OSHA’s 29 CFR 1910.134 and ANSI Z88.2 requirementsmust be followed whenever workplace conditions warrant a respirator’s use.。
1Tarceva产品简介及不良反应处理
酪氨酸激酶(jīméi)结构域改动 1–3
EGFR 失活
ATP
P
P
细胞内酪氨酸激酶结构域 磷酸化，下游信号通路 (tōnglù)激活，肿瘤细胞
发作增殖，迁移，黏附等
特罗凯 与ATP 竞争性结合在 酪氨酸酶结构域，抑制磷酸化， 从而阻断(zǔ duàn)细胞内信号
通路的传导
1.Cohen S, et al. J Biol Chem 1980;255:4834–42; 2.Soderquist AM, et al. Fed Proc 1983;42:2615–20
3.Chinkers M, et al. Nature 1981;290:516–9; 4.Carey et al. Cancer Res 2006;66:8163–71
5.Wells A. Int J Biochem Cell Biol 1999;31:637–43
第九页，共56页。
特罗凯 概略(gàilüè)
特罗凯 —更强的药代动力学特征(tèzhēng)
Cmax(ng/ml)
AUC0-24 (ng•hour/mL)
特罗凯1
( 150mg/d )
吉非替尼2 吉非替尼2 吉非替尼2
( 225mg/d ) ( 525mg/d ) ( 700mg/d )
2,120
307
903
2,146
38,420
5,041 14,727 36,077
药物抑制EGFR后可影响角质化细胞的增生，分化，迁移 以及黏附，这一实践有助于解释丘疹脓疱及单调病的构 Lacouture M. Nat Rev Cancer 2006;6:803–12 成
第十八页，共56页。
表皮生长因子受体抑制剂惹起的皮肤不良反响 (fǎnxiǎng)
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特罗凯说明书
【批准文号】
注册证号H20060108
【中文名称】
盐酸厄洛替尼片
【产品英文名称】
Erlotinib Hydrochloride Tablets
【生产企业】
上海罗氏制药有限公司
【功效主治】
Tarceva用于两个或两个以上化疗方案失败的局部晚期或转移的非小细
胞肺癌的三线治疗。
【化学成分】
每片内含150mg厄洛替尼（以盐酸厄洛替尼形式存在）。
【药理作用】
Tarceva的抗肿瘤作用机制主要为抑制表皮生长因子（EGFR）酪氨酸激酶胞内磷酸化。
【药物相互作用】
【不良反应】
最常见的不良反应是皮疹和腹泻，3/4度皮疹和腹泻的发生率分别为9%
和6%，皮疹的中位出现时间是8天，腹泻中位出现时间为12天。
发生率大于10%的不良反应有：皮疹、腹泻、食欲减低、疲劳、呼吸困难、咳嗽、恶心、感染、呕吐、口腔炎、瘙痒、皮肤干燥、结膜炎、角膜结膜炎、腹痛。
肺毒性：有较少的报道提示在接受Tarceva治疗的NSCLC患者或其他实体瘤患者中可出现严重的间质性肺病（ILD），甚至导致死亡。
在随机对照研究中，ILD的发生率是0.8%，并且这一发生率在Tarceva治疗组和安慰剂组是相同的。
报道的ILD包括：肺炎、间质性肺炎、间质性肺病、闭塞性细支气管炎、肺纤维化、急性呼吸应激综合征和肺渗出。
症状发生于治疗后5天~超过9个月，中位发生时间为47天。
多数患者常有混杂因素导致ILD发生，如：之前有化疗/放疗、原有实质性肺疾病、肺转移或肺部感染。
当有新出现的、难以解释的肺部症状，例如：呼吸困难、咳嗽、发热等，需进行检查评价，一旦诊断ILD，应停止继续使用Tarceva，并采取适当治疗。
肝毒性：Tarceva治疗可引起无症状的肝转氨酶升高，因此，治疗期间应定期复查肝功能，包括：转氨酶、胆红素、碱性磷酸酶等，如果肝功能损害严重应减量或停药。
肝功能损害常为暂时性的或伴有肝转移。
较少报道有胃肠道出血，常发生于同时应用华法林的患者，所以，同时服用华法林或其他抗凝剂的患者应监测凝血酶原时间。
老年患者：安
全性和药代动力学在年轻人和老年患者中无明显差异，因此，应用于老年患者时不建议调整剂量。
【禁忌症】
对本品及成份过敏者禁用。
【产品规格】
150mg
【用法用量】
本品必须在有此类药物使用经验的医生指导下使用，并仅在国家肿瘤药物临床试验基地或三级甲等医院使用。
厄洛替尼单药用于非小细胞肺癌的推荐剂量为150mg/日，至少在进食前1小时或进食后2小时服用。
持续用药直到疾病进展或出现不能耐受的毒性反应。
无证据表明进展后继续治疗能使患者受益。
【贮藏方法】
25℃保存，15℃～30℃之间也可接受。
【注意事项】
本品必须在有此类药物使用经验的医生指导下使用，并仅在国家肿瘤药物临床试验基地或三级甲等医院使用。
特罗凯
【药品名称】
商品名：特罗凯
通用名：盐酸厄洛替尼片
【规格】150mg
【生产厂家】罗氏集团
【适应症】用于两个或两个以上化疗方案失败的局部晚期或转移的非小细胞肺癌的三线治疗。
【用法与用量】本品必须在有此类药物使用经验的医生指导下使用，并仅在国家肿瘤药物临床试验基地或三级甲等医院使用。
厄洛替尼单药用于非小细胞肺癌的推荐剂量为150mg/日，至少在进食前1小时或进食后2小时服用。
持续用药直到疾病进展或出现不能耐受的毒性反应。
无证据表明进展后继续治疗能使患者受益。
【规格】150mg
【生产厂家】罗氏集团
【适应症】用于两个或两个以上化疗方案失败的局部晚期或转移的非小细胞肺癌的三线治疗。
【用法与用量】本品必须在有此类药物使用经验的医生指导下使用，并仅在国家肿瘤药物临床试验基地或三级甲等医院使用。
厄洛替尼单药用于非小细胞肺癌的推荐剂量为150mg/日，至少在进食前1小时或进食后2小时服用。
持续用药直到疾病进展或出现不能耐受的毒性反应。
无证据表明进展后继续治疗能使患者受益。
【成份】每片内含150mg厄洛替尼（以盐酸厄洛替尼形式存在）
【性状】圆形、双凸、白色包衣片，一面印有棕色"T"和"150"，另一面空白。
【药代动力学】
Tarceva口服后60%吸收，半衰期约36小时，主要由CYP3A4代谢清除。
口服Tarceva150mg的生物利用度约60%，4小时后达血浆峰浓度。
对591例接受单药Tarceva治疗的药代动力学分析显示，达到稳定血药浓度需7-8天，患者的年龄、体重、性别与药物的清除速率无显著关系，吸烟可使药物清除率增加24%。
【禁忌症】对本品及成份过敏者禁用。
【不良反应】
最常见的不良反应是皮疹和腹泻，3/4度皮疹和腹泻的发生率分别为9%和6%，皮疹的中位出现时间是8天，腹泻中位出现时间为12天。
发生率大于10%的不良反应有：皮疹、腹泻、食欲减低、疲劳、呼吸困难、咳嗽、恶心、感染、呕吐、口腔炎、瘙痒、皮肤干燥、结膜炎、角膜结膜炎、腹痛。
肺毒性：
有较少的报道提示在接受Tarceva治疗的NSCLC患者或其他实体瘤患者中可出现严重的间质性肺病（ILD），甚至导致死亡。
在随机对照研究中，ILD的发生率是0.8%，并且这一发生率在Tarceva治疗组和安慰剂组是相同的。
报道的ILD包括：肺炎、间质性肺炎、间质性肺病、闭塞性细支气管炎、肺纤维化、急性呼吸应激综合征和肺渗出。
症状发生于治疗后5天~超过9个月，中位发生时间为47天。
多数患者常有混杂因素导致ILD发生，如：之前有化疗/放疗、原有实质性肺疾病、肺转移或肺部感染。
当有新出现的、难以解释的肺部症状，例如：呼吸困难、咳嗽、发热等，需进行检查评价，一旦诊断ILD，应停止继续使用Tarceva，并采取适当治疗。
肝毒性：
Tarceva治疗可引起无症状的肝转氨酶升高，因此，治疗期间应定期复查肝功能，包括：转氨酶、胆红素、碱性磷酸酶等，如果肝功能损害严重应减量或停药。
肝功能损害常为暂时性的或伴有肝转移。
较少报道有胃肠道出血，常发生于同时应用华法林的患者，所以，同时服用华法林或其他抗凝剂的患者应监测凝血酶原时间。
老年患者：
安全性和药代动力学在年轻人和老年患者中无明显差异，因此，应用于老年患者时不建议调整剂量。
【注意事项】本品必须在有此类药物使用经验的医生指导下使用，并仅在国家肿瘤药物临床试验基地或三级甲等医院使用。
【贮存】25℃保存，15℃～30℃之间也可接受。
【包装】PVC泡罩包装；30片/盒。
【有效期】36个月
【进口药品注册证号】H20060108
【生产企业】Roche Pharma（Schweiz）Ltd.
本文由特罗凯格列卫整理！。